FDA.reportPublic FDA data

Phenazopyridine Hydrochloride

Product NDC
65162-682
11-digit product format
651620682
Labeler code
65162
Product ID
65162-682_9b599d15-523d-4e57-a844-800d995d35e5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Phenazopyridine
Dosage form
TABLET
Route
ORAL
Labeler
Amneal Pharmaceuticals LLC
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2011-02-01
Substance
PHENAZOPYRIDINE HYDROCHLORIDE
Active strength
200 mg/1
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Phenazopyridine Hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PHENAZOPYRIDINE HYDROCHLORIDE200 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
0EWG668W17Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1094104Internal RxNorm lookup
1094107Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
b424b50f-990b-4018-a815-0311693cabb3Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65162-682-10Phenazopyridine Hydrochloride100 in 1 BOTTLETABLET10013

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65162-682PHENAZOPYRIDINE HYDROCHLORIDE (PHENAZOPYRIDINE) TABLET [AMNEAL PHARMACEUTICALS LLC]13Current NDC, Legacy NDC, 1 package rows20241031_b424b50f-990b-4018-a815-0311693cabb3.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Phenazopyridine HydrochloridePHENAZOPYRIDINEAmneal Pharmaceuticals LLCb424b50f-990b-4018-a815-0311693cabb32024-10-30Adverse reactionsExact identifier
ndc (product): 65162-682

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1094104phenazopyridine HCl 200 MG Oral TabletPSN6ac0f3ce-0cc2-403c-946d-13b285ae98aa100
1094104phenazopyridine hydrochloride 200 MG Oral TabletSCD6ac0f3ce-0cc2-403c-946d-13b285ae98aa100
1094104phenazopyridine HCl 200 MG Oral TabletPSNc1591037-62f4-469f-8bb2-a82e49dfbecf15
1094104phenazopyridine hydrochloride 200 MG Oral TabletSCDc1591037-62f4-469f-8bb2-a82e49dfbecf15
1094107phenazopyridine HCl 100 MG Oral TabletPSNb424b50f-990b-4018-a815-0311693cabb313
1094104phenazopyridine HCl 200 MG Oral TabletPSNb424b50f-990b-4018-a815-0311693cabb313
1094107phenazopyridine hydrochloride 100 MG Oral TabletSCDb424b50f-990b-4018-a815-0311693cabb313
1094104phenazopyridine hydrochloride 200 MG Oral TabletSCDb424b50f-990b-4018-a815-0311693cabb313
1094104phenazopyridine HCl 200 MG Oral TabletPSN82dc87bb-ba27-4b86-9bc9-18492975ac9f9
1094104phenazopyridine hydrochloride 200 MG Oral TabletSCD82dc87bb-ba27-4b86-9bc9-18492975ac9f9
1094104phenazopyridine HCl 200 MG Oral TabletPSNd8155f91-d650-4021-91ee-f3b6c1055a366
1094104phenazopyridine HCl 200 MG Oral TabletPSN900222e8-fc92-4d73-b3d5-1636e717bd656
1094104phenazopyridine hydrochloride 200 MG Oral TabletSCD900222e8-fc92-4d73-b3d5-1636e717bd656
1094104phenazopyridine hydrochloride 200 MG Oral TabletSCDd8155f91-d650-4021-91ee-f3b6c1055a366
1094104phenazopyridine HCl 200 MG Oral TabletPSNc0e5d32e-075f-4c76-8332-a06560001efe5
1094104phenazopyridine hydrochloride 200 MG Oral TabletSCDc0e5d32e-075f-4c76-8332-a06560001efe5
1094104phenazopyridine HCl 200 MG Oral TabletPSNc77eb633-9176-17ce-e053-2995a90a38803
1094104phenazopyridine hydrochloride 200 MG Oral TabletSCDc77eb633-9176-17ce-e053-2995a90a38803
1094104phenazopyridine HCl 200 MG Oral TabletPSNf2f3e29f-9553-f7c3-e053-2995a90aff362
1094104phenazopyridine HCl 200 MG Oral TabletPSNf40e173c-907a-648c-e053-2a95a90a9c872
1094104phenazopyridine hydrochloride 200 MG Oral TabletSCDf2f3e29f-9553-f7c3-e053-2995a90aff362
1094104phenazopyridine hydrochloride 200 MG Oral TabletSCDf40e173c-907a-648c-e053-2a95a90a9c872
1094104phenazopyridine HCl 200 MG Oral TabletPSN427b6ffb-3ff1-932f-e063-6394a90ae8b91
1094104phenazopyridine HCl 200 MG Oral TabletPSNe018e176-c4ec-42a2-9119-f1278cfa719a1
1094104phenazopyridine HCl 200 MG Oral TabletPSN3c9b98b0-72a5-44c5-a4de-7e950c5176c91
1094104phenazopyridine hydrochloride 200 MG Oral TabletSCD427b6ffb-3ff1-932f-e063-6394a90ae8b91
1094104phenazopyridine hydrochloride 200 MG Oral TabletSCDe018e176-c4ec-42a2-9119-f1278cfa719a1
1094104phenazopyridine hydrochloride 200 MG Oral TabletSCD3c9b98b0-72a5-44c5-a4de-7e950c5176c91

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65162-682-1065162068210100 TABLET in 1 BOTTLE (65162-682-10) 100 tablet2011-02-010000-00-00NoNoCurrent